Kit packaging of drug delivery devices with useful adjunct items

ABSTRACT

A kit containing a complete set of items needed to implant a sustained ocular or intraocular drug delivery system, including, but not limited to, injection devices, topical and injectable medications, surgical instruments, sutures and suturing needles, and eye covers. Provision of the set of items in a kit simplifies preparation for insertion of drug delivery means, reduces the cost of such preparation, reduces the likelihood of errors in preparation or selection of appropriate items during surgery, reduces the complexity of maintenance of sterile conditions, and ultimately reduces the cost of delivering ocular care.

FIELD OF THE INVENTION

[0001] This invention relates to the sterile packaging of medicalimplements, medications, and supporting items for surgery, and morespecifically to the sterile packaging of medical implements,medications, and supporting items together in a kit to be used forocular and intraocular surgery.

BACKGROUND OF THE INVENTION

[0002] The sterile packaging of items in a kit for use in medicaltreatment of a patient has become increasingly important for thefollowing reasons: 1) the increasing complexity and variety oftreatments available makes assembly of individual items alabor-intensive and error-prone task; 2) medical personnel need to meetan elevated standard for sterility due partly to the increased presenceof antibiotic-resistant microbes; 3) the availability of lower-costmethods of fabricating, assembling, and packaging surgical and othertreatment items more than offsets the costs of having staff locate,assemble, and lay out the same items for a treatment.

[0003] Such kits of items have been developed for certain types ofsurgery and treatment. U.S. Pat. No. 6,426,041 (Smith) teaches thefabrication of a multipurpose surgical instrument tray to simplify andspeed presentation of any of a kit of instruments during surgery, butomits any further packaging. U.S. Pat. No. 5,931,303 (Salvadori) teachesfabrication of a compact, pocketed wrapping for a medical procedure kit,and a process for using the kit. U.S. Pat. No. 4,523,679 (Paikoff etal.) teaches the fabrication of pre-sterilized medical procedure kitpackages for surgical procedures. U.S. Pat. No. 6,116,426 (Slonim)teaches an emergency medical kit containing instruments, supplies, andother items for the treatment of eye injuries. No instances of the priorart teach a kit for insertion of a capsule or suture tab for sustainedocular drug delivery. Such a kit would simplify surgical preparation andexecution for ocular treatment, and cut the costs of delivering care.

SUMMARY OF THE INVENTION

[0004] The invention packages in kit form a complete set of items neededto implant a sustained ocular or intraocular drug delivery system,including, but not limited to, injection devices, topical and injectablemedications, surgical instruments, sutures and suturing needles, and eyecovers. The resulting kit simplifies preparation for insertion of drugdelivery means, reduces the cost of such preparation, reduces thelikelihood of errors in preparation or selection of appropriate itemsduring surgery, reduces the complexity of maintenance of sterileconditions, and ultimately reduces the cost of delivering ocular care ata time when the frequency of insertion of ocular and intraocular drugdelivery implants is growing.

BRIEF DESCRIPTION OF THE DRAWINGS

[0005]FIG. 1 shows a flat layout of one embodiment of the kit.

[0006]FIG. 2 shows a box layout of an alternate embodiment of the kit.

DETAILED DESCRIPTION OF THE INVENTION

[0007] The invention is a portable kit having sterile seals forperforming ocular or intraocular implanting of an ocular drug deliverysystem. The invention includes as its required components a portableprotective container, a storage compartment in the container containingboth a packaged injectable ocular drug delivery device such as a suturetab with attached capsule and a packaged injection device, and one ormore compartments in the container holding packaged sutures and packagedsuture needles for attaching the suture tab ocularly. See FIGS. 1 and 2.FIG. 1 shows the layout of typical compartments for the requiredcomponents in a larger flat container 10, where compartment 12 containsthe delivery device and the injection device, compartment 14 containsthe packaged sutures, and compartment 16 contains the packaged sutureneedles. FIG. 2 shows the layout typical compartments for the requiredcomponents in a smaller box-shaped container 20 with lid 21, wherecompartment 22 contains the delivery device and the injection device,compartment 24 contains the packaged sutures, and compartment 26contains the packaged suture needles. The layouts shown in the figuresrepresent examples of many possible layouts for the invention.

[0008] The kit's portable protective container may be formed either as ablister pack or as a clamshell, made of sterilization-safe plastics suchas high-density polyethylene (HDPE), polyethylene terephthalate (PET orPETg), or polycarbonate. These plastics are not harmed by standardsterilization methods such as ethylene oxide, gamma radiation, electronbeam radiation, or autoclaving. The container may have a latch andhinge, allowing closing and locking, and opening and unlocking. Aprotective seal, added once the kit is filled initially with itscontents, protects all the contents from contamination or damage due toaccidental opening and provides a first level of assurance of sterilityof the contents. Two layers of protective wrappers surrounding thecontainer provide for proper maintenance of sterile conditions whentransporting the kit into a sterile environment for use. Optionalexternal features of the container and outer wrapper such as a handle,grip, or strap provide for ease of carrying and storage.

[0009] The kit incorporates additional storage compartments for itemsusually required for ocular implanting of a drug delivery device. Thissecond set of compartments may be incorporated in the kit as a separatelayer (‘tray’) or group. This separation allows the surgeon or thehospital to choose either a more basic kit requiring separate provisionof medications, instruments, and other surgical items, or a morecomplete kit including most or all medications, instruments, and otheritems needed for ocular implantation of a drug delivery system.

[0010] One set of the additional compartments contains medications, bothinjectable and topical, in sterile packaged form ready to use. Themedications to be used include those specific to ocular surgery such ascycloplegics, mydriatics, and miotics; those anti-infectives andanti-inflammatory agents and steroids compatible with ocular use; andocular anesthetics, irrigating solutions, lubricants, sterilizers, andexternal cleansers.

[0011] A second set of additional compartments contains packaged,sterilized surgical instruments of use in ocular surgery for implantingan ocular drug delivery device. The instruments to be used includecannulas, trocars, keratomes, scalpels, forceps, hooks, and scissors.For the ocular surgery needed for implantation of an ocular drugdelivery system, instruments must be available to perform incisions,dilations, and positioning, implanting, and suturing of the drugdelivery system.

[0012] A third set of added compartments contains packaged eye covers,packaged dressings and wipes, and related materials.

[0013] The fabrication of the kit begins with the making of the portableprotective container by injection molding or other process suitable foruse with the plastics to be used. The container may take the form of ablister pack or a clamshell. The container may be fabricated in onepiece with a hinge, may have separate base and lid with a snap-in hinge,or may be fabricated as a set of ‘trays’ of compartments with a separatelid. Compartments in the container are either molded into the containeror its parts in the initial fabrication process, or are separatelymolded to fit snugly within the container.

[0014] The required section of the container, that is, the compartmentsfor the packaged injectable ocular drug delivery device and the packagedsutures and packaged suture needles, is set apart from the remainingthree sections of compartments used for medications, instruments, anddressings. Once each section of compartments is installed in the kit, itis provisioned with the desired items for each compartment.

[0015] When all desired and required items are stored in the kit, thekit is closed. A protective seal is added to guarantee an untamperedkit, and the kit is then sealed inside inner and outer protective sealsto allow for sterile handling as required.

[0016] In one embodiment the kit has a minimal number of components thatincludes an inserter and an intraocular drug in its intraocularcontainer. The drug container may be as small as one or severalmillimeter in size and the kit may include one or more drug container isdifferent sizes. As an option, the inserter may be preloaded with apredetermined quantity of intraocular drug in its suitable intraocularcontainer. The inserter is about the size of a ball point pen and iselongated with an opening and holding means at that one end for holdingthe intraocular drug container. The other end of inserter has a releasemechanism that is operable to release the intraocular drug containerfrom the one end. The inserter and the drug container may be enclosed ina sealed sterile package that could include one or more pouches ofsterile material. Another package for the kit includes a plastic traywith compartments for holding the inserter, the drug containers, andother items such as sutures. The tray is sealed with medical paper orother suitable porous material that has pores large enough to allowpassage of sterilizing gas but small enough to exclude microbes. Typicalmaterial such as Tyvek™ filter material could cover the top of the tray.Larger kit with more items could use the clamshell arrangement describedbelow.

[0017] The container may have an external grip, handle, or strap addedfor ease of carrying and storage. The horizontal dimensions of the kit'sportable protective container are in the embodiment outlined in FIG. 1approximately eight inches by eleven inches, and in the embodimentoutlined in FIG. 2 approximately four inches by five and a half inches.The vertical dimension of the kit's container is between two and threeinches per layer of compartments.

1. A kit for performing ocular or intraocular implanting of an oculardrug delivery system, comprising: a portable protective container; andat least one first compartment in the container for storage of apackaged injectable ocular drug delivery device and a packaged injectiondevice, containing the packaged injectable ocular drug delivery deviceand the packaged injection device.
 2. The kit of claim 1 furthercomprising at least one second compartment in the container for storageof sutures and suture needles, containing one or more packaged suturesand one or more packaged suture needles.
 3. The kit of claim 1 whereinthe portable protective container further comprises: a protective sealto preserve sterility of the contents of the container; a base for thecontainer, divided into the compartments of the container; a lid forprotecting the contents of the compartments of the container; means forfastening the lid to the base; means for opening, closing, locking, andunlocking the container; and means for carrying the container securely.4. The kit of claim 1 wherein the container comprises one or morepouches, each pouch comprising a sterile sealed compartment.
 5. The kitof claim 1 wherein the package is a tray with one or more compartmentswith medical paper or filter material with pores large enough to admitsterilizing gas and small enough to exclude microbes.
 6. The kit ofclaim 1 wherein the portable protective container further comprises: anouter protective wrapper for protection during transportation andstorage; and an inner protective wrapper for maintenance of generalsterility of kit contents.
 7. The kit of claim 1 wherein the portableprotective container further comprises a blister pack comprised of oneor more plastics capable of surgical sterilization by ethylene oxide,gamma radiation, electron beam radiation, autoclave, or other methodsmeeting generally accepted surgical standards.
 8. The kit of claim 1wherein the portable protective container further comprises a blisterpack comprised of one or more plastics selected from the groupconsisting of high-density polyethylene (HDPE), polyethyleneterephthalate (PET or PETg), polycarbonate, polyvinyl chloride (PVC),and styrene.
 9. The kit of claim 1 wherein the portable protectivecontainer further comprises a clamshell package comprised of one or moreplastics capable of surgical sterilization by ethylene oxide, gammaradiation, electron beam radiation, autoclave, or other methods meetinggenerally accepted surgical standards.
 10. The kit of claim 1 whereinthe portable protective container further comprises a clamshell packagecomprised of one or more plastics selected from the group consisting ofhigh-density polyethylene (HDPE), polyethylene terephthalate (PET orPETg), polycarbonate, polyvinyl chloride (PVC), and styrene.
 11. The kitof claim 1 further comprising: at least one third compartment in thecontainer for storage of eye covers and dressings, containing one ormore packaged eye covers; at least one fourth compartment in thecontainer for storage of medications; and at least one fifth compartmentin the container for storage of surgical instruments.
 12. The kit ofclaim 8 wherein the at least one fourth compartment in the container forstorage of medications contains one or more packaged medications fromthe group consisting of cycloplegics, mydriatics, and miotics.
 13. Thekit of claim 11 wherein the at least one fourth compartment in thecontainer for storage of medications contains one or more packagedmedications from the group consisting of anti-infectives,anti-inflammatory agents, steroids, and combination products containinganti-infectives and anti-inflammatory agents.
 14. The kit of claim 11wherein the at least one fourth compartment in the container for storageof medications contains one or more packaged medications from the groupconsisting of anesthetics, irrigating solutions, lubricants,sterilizers, and external cleansers.
 15. The kit of claim 11 wherein theat least one fifth compartment in the container for storage of surgicalinstruments contains one or more packaged surgical instruments from thegroup consisting of cannulas, trocars, keratomes, scalpels, forceps,hooks, and scissors.
 16. A method for fabricating a kit for performingocular or intraocular implanting of an ocular drug delivery system,comprising the steps of: fabricating a portable protective container;fabricating at least one first compartment in the container for storageof a packaged injectable ocular drug delivery device, containing thepackaged injectable ocular drug delivery device and a packaged injectiondevice; and fabricating at least one second compartment in the containerfor storage of sutures and suture needles, containing one or morepackaged sutures and one or more packaged suture needles.
 17. The methodof claim 16 wherein the step of fabricating the portable protectivecontainer further comprises the steps of: fabricating a protective sealto preserve sterility of the contents of the container; fabricating abase for the container, divided into the compartments of the container;fabricating a lid for protecting the contents of the compartments of thecontainer; fabricating a means for fastening the lid to the base;fabricating a means for opening, closing, locking, and unlocking thecontainer; and fabricating a means for carrying the container securely.18. The method of claim 16 wherein the step of fabricating the portableprotective container further comprises the steps of: fabricating anouter protective wrapper for protection during transportation andstorage; and fabricating an inner protective wrapper for maintenance ofgeneral sterility of kit contents.
 19. The method of claim 16 whereinthe step of fabricating the portable protective container furthercomprises the step of fabricating a blister pack comprised of one ormore plastics capable of surgical sterilization by ethylene oxide, gammaradiation, electron beam radiation, autoclave, or other methods meetinggenerally accepted surgical standards.
 20. The method of claim 16wherein the step of fabricating the portable protective containerfurther comprises the step of fabricating a blister pack comprised ofone or more plastics selected from the group consisting of high-densitypolyethylene (HDPE), polyethylene terephthalate (PET or PETg),polycarbonate, polyvinyl chloride (PVC), and styrene.
 21. The method ofclaim 16 wherein the step of fabricating the portable protectivecontainer further comprises the step of fabricating a clamshell packagecomprised of one or more plastics capable of surgical sterilization byethylene oxide, gamma radiation, electron beam radiation, autoclave, orother methods meeting generally accepted surgical standards.
 22. Themethod of claim 16 wherein the step of fabricating the portableprotective container further comprises the step of fabricating aclamshell package comprised of one or more plastics selected from thegroup consisting of high-density polyethylene (HDPE), polyethyleneterephthalate (PET or PETg), polycarbonate, polyvinyl chloride (PVC),and styrene.
 23. The method of claim 16 further comprising the steps of:fabricating at least one third compartment in the container for storageof eye covers and dressings, containing one or more packaged eye covers.fabricating at least one fourth compartment in the container for storageof medications; and fabricating at least one fifth compartment in thecontainer for storage of surgical instruments.
 24. The method of claim23 wherein the step of fabricating the at least one fourth compartmentin the container for storage of medications further comprises the stepof storing one or more packaged medications from the group consisting ofcycloplegics, mydriatics, and miotics in the at least one fourthcompartment in the container.
 25. The method of claim 23 wherein thestep of fabricating the at least one fourth compartment in the containerfor storage of medications further comprises the step of storing one ormore packaged medications from the group consisting of anti-infectives,anti-inflammatory agents, steroids, and combination products containinganti-infectives and anti-inflammatory agents in the at least one fourthcompartment in the container.
 26. The method of claim 23 wherein thestep of fabricating the at least one fourth compartment in the containerfor storage of medications further comprises the step of storing one ormore packaged medications from the group consisting of anesthetics,irrigating solutions, lubricants, sterilizers, and external cleansers inthe at least one fourth compartment in the container.
 27. The method ofclaim 23 wherein the step of fabricating the at least one fifthcompartment in the container for storage of surgical instruments furthercomprises the step of storing one or more packaged surgical instrumentsfrom the group consisting of cannulas, trocars, keratomes, scalpels,forceps, hooks, and scissors in the at least one fifth compartment inthe container.
 28. A kit for performing ocular or intraocular implantingof an ocular drug delivery system, comprising: a portable protectivecontainer; means for storage of a packaged injectable ocular drugdelivery device and a packaged injection device, containing the packagedinjectable ocular drug delivery device and the packaged injectiondevice; and means for storage of sutures and suture needles, containingone or more packaged sutures and one or more packaged suture needles.29. The kit of claim 28 wherein the portable protective containerfurther comprises: means for preserving sterility of the contents of thecontainer; a base for the container, divided into the compartments ofthe container; means for protecting the contents of the compartments ofthe container; means for opening, closing, locking, and unlocking thecontainer; and means for carrying the container securely.
 30. The kit ofclaim 28 wherein the portable protective container further comprises:means for protection during transportation and storage; and means formaintenance of general sterility of kit contents.
 31. The kit of claim28 wherein the portable protective container further comprises storagemeans capable of surgical sterilization by ethylene oxide, gammaradiation, electron beam radiation, autoclave, or other methods meetinggenerally accepted surgical standards.
 32. The kit of claim 28 furthercomprising: means for storage of eye covers and dressings, containingone or more packaged eye covers. means for storage of medications; andmeans for storage of surgical instruments.
 33. The kit of claim 32wherein the means for storage of medications contains one or morepackaged medications from the group consisting of cycloplegics,mydriatics, and miotics.
 34. The kit of claim 32 wherein the means forstorage of medications contains one or more packaged medications fromthe group consisting of anti-infectives, anti-inflammatory agents,steroids, and combination products containing anti-infectives andanti-inflammatory agents.
 35. The kit of claim 32 wherein the means forstorage of medications contains one or more packaged medications fromthe group consisting of anesthetics, irrigating solutions, lubricants,sterilizers, and external cleansers.
 36. The kit of claim 32 wherein themeans for storage of surgical instruments contains one or more packagedsurgical instruments from the group consisting of a cannulas, trocars,keratomes, scalpels, forceps, hooks, and scissors.
 37. The kit of claim32 wherein the means for storage of an ocular drug delivery systemcontains one or more packaged suture tabs attached to an ocular drugdelivery system.